1. Field of the Invention
The invention is in the field of sample distribution and inventory control.
2. Description of the Background Art
The Prescription Drug Marketing Act of 1987 (PDMA) passed by the US Congress attempts to regulate and track the disbursement of sample pharmaceutical drugs and controlled substances to licensed practitioners nationwide. Prior to PDMA, there was no specific legislation regulating the flow of product samples to practitioners. As a result, significant diversion of substances, including prescription drugs and controlled drugs by practitioners and pharmaceutical sales representatives as well other parties was not only possible, but also prevalent. Pharmaceutical sales representatives meet with and distribute free samples of pharmaceutical products to practitioners. The Pharmaceutical Industry builds sales of its products indirectly, through the prescription of specific drugs by practitioners, to the general public.
The PDMA of 1987 did much to address the issues contributing to drug diversion, mandating specific tracking mechanisms and data elements required to be monitored in an effort to detect and prevent drug diversion. These measures included paper documents (Sample Disbursement Forms—SDFs), which are to be filled out by pharmaceutical representatives and signed by licensed practitioners. These forms capture information about the date of the sampling activity, the product disbursed, quantities, practitioner information such as name, address, DEA#, etc. In this manner, a comprehensive record of the transaction would be available for audit by both pharmaceutical companies as well as outside regulatory agencies such as the Drug Enforcement Agency (DEA) and Food and Drug Administration (FDA).
While certainly better than no system at all, these paper-based systems still have significant drawbacks such as:    1.) rely on the representative to send in forms in a timely manner for processing. As a matter of routine, representatives often wait weeks to send in forms, contributing to a significant time lag between the time of transaction and ultimate receipt of completed data by a pharmaceutical client;    2.) errors related to incorrect completion of forms and data capture of form information;    3.) difficult or sometimes impossible to reconcile sample inventories due to time delay in processing of data from multiple disparate sources, using time-intensive processes; and    4.) significant processing time.This process is generally referred to as a “rep-centric” process. i.e. one in which a pharmaceutical sales representative determines all actions related to the disbursement of product samples and recording of this activity, including accuracy and timeliness of the submission.
The computing revolution of the 1980's did have an effect however. By the early/mid 1990's a number of companies developed electronic versions of these paper-based sample-tracking systems. Then, as now, most or all of these systems promise tremendous improvement over paper-based processing. Unfortunately, however, significant drawbacks remain, such as:    1.) systems are still completely rep-centric, that is, they give complete authority to the sales representative to create/edit records and information about sampling transactions.    2.) electronic systems (at the time) could not offer electronic signatures that were legally binding (as is an original signature on a sample disbursement form). For this reason, most electronic Sales Force Automation systems (SFA's) work in concert with, rather than instead of, existing paper-based systems. This is generally referred to as a hybrid or dual system.    3.) electronic hybrid systems rely on a representative to act as data-entry clerks by replicating the paper-based data in the electronic environment, resulting in not only inaccurate data, but also a reduction in valuable selling time by the sales force.    4.) ultimately, electronic systems still relied on the representative to synchronize his/her transaction data in a timely manner. Even if a diligent representative synchronized weekly, there still exists a significant time lag in receipt of this sensitive data.    5.) hybrid systems, by definition, create additional disparate data streams. Although these streams are meant to be identical, they often are not, resulting in the need to reconcile the data streams.    6.) the electronic/hybrid systems report data from the disbursement after the transaction has occurred. There is no reasonable way to enforce the timely submission (synchronization) of this information in these systems.Presently, no system, paper or electronic exists which addresses these and other driving needs of PDMA compliance, as well as additional data requirements of pharmaceutical companies.
In an effort to address these needs, the hereindisclosed system is a completely new approach to sample accountability. By leveraging existing widespread technologies and re-engineering the sample accountability process flow, this system promises to completely recreate the sample disbursement process, as it presently exists.